Automation Vendor or Partner?

As a result of growing challenges such as an expanding global market, increased competition, reduced product life cycles, modular processes, and changing product demand, pharmaceutical companies are searching for innovative ways to improve their production processes. Historically, the pharmaceutical industry has been conservative in adopting new manufacturing technologies. This caution can impede the ability to operate best-in-class facilities. But innovative solutions can bring benefits such as the following:

Reduced production cycle times by using on-, in-, and/or at-line measurements and controls

As companies strive to achieve these improvements with fewer employees and resources, many are looking at automation suppliers as strategic partners rather than as vendors. The changing expectation is influencing automation suppliers' strategies and investments. Automation suppliers are expanding product solutions to perform new functions (e.g., ISA95 Level 3) and broadening their service capability to become main automation contractors (MACs). These strategies are reviewed below.

Expanding product functionality

In the current market environment, automation suppliers are investing in solutions that address ISA95 Level 3 operations-management functionality. The ISA95 Enterprise-Control System Integration standard helps manage people, equipment, materials, and energy within a manufacturing facility by defining data models, work activity, and the information exchange of operations management activities.

Joanne Salazar

The ISA95 standard divides the management of manufacturing operations into four categories: production operations, inventory operations, quality operations, and maintenance operations. The activities defined in Levels 1–3 are critical to plant safety, reliability, efficiency, product quality, and maintaining regulatory compliance. Within Level 3, several operations-management functions are defined for each of these four categories: definition, resource management, detailed scheduling, dispatching, execution management, data collection, and analysis.

Three ISA95 concepts critical to pharmaceutical-operations management include integrated workflow and recipe optimization, integrated documentation and document management, and integrated manufacturing operations throughout the entire facility. A single recipe, that addresses both manual and automated activities can optimize operations by reducing operator errors and variability, coordinating process steps, and minimizing engineering efforts. A single recipe also enables comprehensive batch documentation records to be generated in real time.

Managing documents extends far beyond electronic batch records to include information such as material-safety data sheets, standard operating procedures, design documents, testing documents, and training records. Regardless of the format or source, this information needs to be managed throughout a product's life cycle, and any change management must be addressed.

In addition, advanced control techniques such as real-time principle component analysis modeling can help optimize the manufacturing process. Predictive diagnostics can be implemented to avoid further equipment deviations. Other technology enhancements that improve manufacturing include wireless access and radio-frequency identifcation (RFID).

With these technologies, Level 3 solutions facilitate closed-loop control for manufacturing activities, thereby allowing pharmaceutical manufacturers to make business decisions in real time. In turn, the traditional real-time domain of automation suppliers is naturally extended into Level 3 functionality. Manufacturers will realize the benefits of having their complete real-time environment provided by a single partner.